Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: one-year safety and efficacy.

To perform a feasibility study of the safety and efficacy of a corneal-contouring inlay with concurrent laser in situ keratomileusis (LASIK) to treat hyperopic presbyopia. Private clinic, Tijuana, Mexico. Prospective interventional case series. Hyperopic patients received LASIK in both eyes and a corneal inlay under the femtosecond laser flap in the nondominant eye. The inlay is designed to reshape the anterior corneal curvature, creating a near-center multifocal refractive effect. Main safety outcomes were retention of preoperative corrected distance and near visual acuities and reports of adverse events. Efficacy was determined through measurements of near, intermediate, and distance visual acuities and patient questionnaires on visual task ability and satisfaction. The study enrolled 16 patients. All eyes with an inlay achieved an uncorrected near visual acuity (UNVA) of 20/32 or better by the 1-week postoperative examination and at every visit thereafter. The mean monocular and binocular UNVA was 20/27 or better at all visits. The mean binocular uncorrected distance visual acuity improved significantly from 20/53 preoperatively to 20/19 postoperatively (P<10(-5)). One inlay was explanted during the study. At 1 year, all 14 patients analyzed were satisfied or very satisfied with their near, distance, and overall vision. The hydrogel corneal inlay with concurrent LASIK improved uncorrected near, intermediate, and distance visual acuity in hyperopic presbyopic patients with high patient satisfaction and visual task ability. This represents a new indication for this recently developed technology.

Chayet A ，Barragan Garza E 《-》

Safety and efficacy of a hydrogel inlay with laser in situ keratomileusis to improve vision in myopic presbyopic patients: one-year results.

To study the safety and efficacy of implanting a hydrogel corneal inlay (Raindrop Near Vision Inlay) concurrently with performing laser in situ keratomileusis (LASIK) to treat myopic presbyopia and to compare the results with results of the same treatment in emmetropic and hyperopic patients. Two private clinics, Tijuana and Monterrey, Mexico. Prospective nonrandomized clinical trial. Bilateral myopic LASIK was performed and a corneal inlay was concurrently implanted in the nondominant eye under a flap created using a femtosecond laser. Primary safety outcomes were the retention of corrected distance (CDVA) and near (CNVA) visual acuities. Efficacy was evaluated on the basis of uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities. A patient questionnaire was used to assess the preoperative and postoperative incidence of visual symptoms, the ability to perform common tasks with no correction, and patient satisfaction with vision. Thirty eyes were enrolled. At each postoperative visit, the mean CDVA and CNVA were within one half line of preoperative measurements and no eye lost 2 or more lines of CDVA. The mean binocular UDVA, UIVA, and UNVA were better than 20/25 Snellen at all postoperative visits. By 6 months, 93% of patients had a binocular Snellen acuity of 20/25 or better across all visual ranges. According to patient questionnaires, 1 year after surgery, visual symptoms were at preoperative levels, 98% of all visual tasks could be easily performed without correction, and 90% of patients were satisfied or very satisfied with their overall vision. A hydrogel corneal inlay with concurrent LASIK was safe and effective for treating myopic presbyopia. Drs. Garza and Chayet are consultants to and investigators for Revision Optics, Inc.

Garza EB ，Chayet A 《-》

One-year results of simultaneous laser in situ keratomileusis and small-aperture corneal inlay implantation for hyperopic presbyopia: comparison by age.

To compare by age the safety, efficacy, and patient satisfaction after simultaneous laser in situ keratomileusis (LASIK) and small-aperture corneal inlay implantation (Kamra) for hyperopic presbyopia. Shinagawa LASIK Center, Tokyo, Japan. Retrospective comparative cohort study. Simultaneous LASIK and small-aperture corneal inlay implantation were performed in the nondominant eye of hyperopic presbyopic patients with astigmatism. Patients were divided into groups by age as follows: Group 1 (40 to 49 years), Group 2 (50 to 59 years), and Group 3 (60 to 65 years). The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, uncorrected near visual acuity (UNVA), and patient questionnaire results were compared. The study evaluated 277 eyes of 277 patients. All groups achieved a mean UDVA of 20/20, with Group 1, Group 2, and Group 3 gaining 1 line, 2 lines, and 3 lines, respectively. The mean UNVA was J2 with 4 lines gained in Group 1 and J3 with 5 lines gained in Group 2 and Group 3. The mean CDVA and corrected near visual acuity remained the same as at baseline. Simultaneous LASIK and small-aperture corneal inlay implantation for hyperopic presbyopia was a safe and effective treatment option. Although the outcomes were comparable between groups, Group 3 had the largest gain in UDVA and UNVA and the highest patient satisfaction, despite having the lowest reduction in dependence on reading glasses. Taking age into account might help achieve optimum postoperative outcomes and improved patient satisfaction. Dr. Tomita is a consultant to Ziemer Ophthalmic Systems AG, Acufocus, Inc., and Schwind eye-tech-solutions GmbH and Co. KG. Dr. Waring is a consultant to Acufocus, Inc.

Tomita M ，Waring GO 4th 《-》

Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: six-month results.

To evaluate the safety and efficacy of simultaneous Kamra corneal inlay implantation and laser in situ keratomileusis (LASIK) for the treatment of presbyopia in emmetropic, hyperopic, or myopic patients. Private center, Tokyo, Japan. Cohort study. Patients had bilateral LASIK with simultaneous implantation of a corneal inlay in the nondominant eye to treat presbyopia and ametropia between September 2009 and April 2010. The efficacy and safety were determined by the spherical equivalent (SE) in the eye with the inlay. The study enrolled 360 eyes of 180 patients with a mean age of 52.4 years ± 5.1 (SD) (range 41 to 65 years). Sixty-four patients were available for the 6-month postoperative examination. The mean logMAR uncorrected near visual acuity in the eye with the inlay improved 7 lines in hyperopic eyes, 6 lines in emmetropic eyes, and 2 lines in myopic eyes. The mean logMAR uncorrected distance visual acuity improved by 3 lines, 1 line, and 10 lines, respectively. Simultaneous intracorneal inlay implantation and LASIK to treat presbyopia with emmetropia, hyperopia, or myopia was clinically safe and effective, yielding improvement in distance and near visual acuity. Patients were satisfied with decreased dependence on reading glasses regardless of the preoperative SE range. However, postoperative symptoms, such as dry eyes, halo, glare, or night-vision disturbances, occurred occasionally. Dr. Waring has a financial interest in and is world surgical monitor for Acufocus. No other author has a financial or proprietary interest in any material or method mentioned.

Tomita M ，Kanamori T ，Waring GO 4th ，Yukawa S ，Yamamoto T ，Sekiya K ，Tsuru T ... -  《-》

Small-aperture corneal inlay implantation to treat presbyopia after laser in situ keratomileusis.

To evaluate the visual outcomes after implantation of a Kamra small-aperture corneal inlay into a femtosecond-created corneal pocket to treat presbyopia in patients who had previous laser in situ keratomileusis (LASIK). Private center, Tokyo, Japan. Prospective interventional case series. Post-LASIK presbyopic patients had inlay implantation into a corneal pocket created by a femtosecond laser at a depth of 200 μm or 250 μm a minimum of 80 μm below the previous LASIK flap interface in the nondominant eye. Uncorrected and corrected distance visual acuities, near visual acuity, and a patient questionnaire on satisfaction, the use of reading glasses, and visual symptoms were evaluated. The study enrolled 223 eyes (223 patients) with a mean age of 53.6 years (range 44 to 65 years) and a mean manifest spherical equivalent of -0.18 diopter (D) (range -1.00 to +0.50 D). The mean uncorrected distance visual acuity in the operated eye decreased 1 line from 20/16 preoperatively to 20/20 6 months postoperatively (P<.001). The mean uncorrected near visual acuity improved 4 lines from Jaeger (J) 8 to J2 (P<.001). At 6 months, significant improvements were observed in patient dependence on reading glasses and patient satisfaction with vision without reading glasses. The 6-month results suggest that implantation of a small-aperture inlay in post-LASIK presbyopic patients improves near vision with a minimal effect on distance vision, resulting in high patient satisfaction and less dependence on reading glasses. Drs. Tomita and Waring are consultants to Acufocus, Inc. Dr. Tomita is a consultant to Ziemer Group AG. No other author has a financial or proprietary interest in any material or method mentioned.

Tomita M ，Kanamori T ，Waring GO 4th ，Nakamura T ，Yukawa S ... -  《-》